Flexible Randomization's Importance in the Clinical Development Process

Traditional randomization techniques are inadequate for the demands of adaptive trials and other more complex clinical trial designs. In these designs, absolute accurate patient randomization is crucial to executing the trial successfully. Custom-programmed software is often egregiously flawed and typically must be extensively modified - often entirely rewritten - with each successive trial.

Centralized randomization is applicable to any trial, across all therapeutic areas and in conjunction with drug therapies, biologics or medical device studies.

Why Cytel's FlexRandomizer™?

FlexRandomizer™ provides a single source of patient randomization for any clinical study, early or late stage, for designs based on traditional, group-sequential or adaptive statistical methods. The FlexRandomizer™ software suite offers:

• simulation tools to assess alternative randomization approaches during the design stage
• operational randomization schemes for even the most complicated trial designs
• a quality assurance tool to assure that the randomization is proceeding correctly

Originally developed in close collaboration with experts at Wyeth and Merck, Cytel's FlexRandomizer™ is now available to all sponsor organizations.

FlexRandomizer™ has been extensively tested for statistical validity and accuracy in operation. These tests have been thoroughly documented. A detailed operating manual and technical support are also available.